Methadone, Morphine, or Oxycodone in Treating Pain in Patients With Cancer

Pain Clinical Trial

Official title:

A Randomized Comparison of Oral Methadone as a "First-Switch" Opioid Versus Opioid Switching Between Sustained-Release Morphine and Oxycodone for Oncology-Hematology Outpatients With Pain Management Problems: The "Simply Rotate" Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00726830
• Other study ID #: 2007-0791
• Secondary ID: MDA-2007-0791CDR
• Status: Terminated
• Phase: N/A
• Start date: March 2009
• Est. completion date: October 2010

Study information

• Verified date: September 2020
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Methadone, morphine, or oxycodone may help relieve pain caused by cancer. It is not yet known whether methadone is more effective than morphine or oxycodone in treating pain in patients with cancer.

PURPOSE: This randomized clinical trial is studying methadone to see how well it works compared with morphine or oxycodone in treating pain in patients with cancer.

Description:

OBJECTIVES:

Primary

• To compare the effectiveness of an opioid rotation to oral methadone versus an opioid rotation to another long-acting strong opioid (sustained-release morphine or oxycodone) in controlling pain (i.e., analgesia) in patients with cancer.

Secondary

• To compare the tolerability of an opioid rotation to oral methadone versus an opioid rotation to another long-acting strong opioid (sustained-release morphine or oxycodone).

• To identify a subset of patients most likely to benefit from an opioid rotation to oral methadone, in terms of significant improvement in pain control or opioid tolerability.

OUTLINE: This is a multicenter study. Patients are stratified according to their baseline opioid (morphine vs oxycodone). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients are switched from their current opioid medication (oxycodone or morphine) to methadone. Patients receive oral methadone 2-3 times daily for 4 weeks.

• Arm II: Patients currently receiving oxycodone are switched to sustained-release (SR) morphine. Patients currently receiving morphine are switched to SR oxycodone. Patients receive either oral SR morphine or oxycodone 2-3 times daily for 4 weeks.

Patients are assessed for pain control and complete a symptom questionnaire on days 1, 8, 15, 22, and 28.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: October 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Receiving ongoing care in the outpatient medical oncology setting

• Self-reported pain (of any cause) for which long-acting strong opioids (morphine or oxycodone) have been prescribed or administered

• Oral morphine-equivalent daily dose (MEDD) of existing opioid regimen (long-acting or immediate-release) 40-300 mg/day

• Worst pain score on a scale of 0 (no pain) to 10 (worst pain) of = 5 for = 1 week duration based on verbal self-report AND/OR = 1 persistently bothersome symptom attributed to an opioid side effect (e.g., fatigue, confusion, depressed level of consciousness, memory loss, personality change, anorexia, constipation, dehydration, nausea, vomiting, weight loss, pruritus, urticaria, impotence, reduced libido, and urinary retention or hesitancy)

PATIENT CHARACTERISTICS:

• None of the following conditions that could predispose the patient to prolonged QT interval-associated tachycardia:

• Serum potassium < 3.0 mg/dL

• Cocaine abuse within the past 3 months

• Family history of sudden death

• Advanced heart failure (ejection fraction < 40% and/or New York Heart Association (NYHA) class III or IV heart disease)

• No known or suspected cognitive impairment that could interfere with adherence to the medication plan or self-report of symptoms and side effects

• Not pregnant or nursing

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• More than 4 weeks since prior radiotherapy or surgery for local control of cancer or pain palliation

• More than 60 days since prior use of the same long-acting opioid (i.e., the new long-acting opioid) that patient is switching to on the study

• More than 12 weeks since prior methadone therapy

• More than 3 days since prior and no concurrent transdermal fentanyl, oxymorphone, or buprenorphine

• Concurrent systemic anticancer therapy or bisphosphonates allowed provided therapy was initiated = 4 weeks ago

• Concurrent tricyclic antidepressants, Nonsteroidal Antiinflammatory Drugs (NSAIDs), anticonvulsants, or other adjuvant analgesics or psychostimulants allowed provided therapy was initiated = 2 weeks ago

• Dose expected to remain stable until after the first week of opioid rotation on study

• No concurrent methadone maintenance therapy for opioid addiction

• No concurrent intrathecal infusion of analgesics

• No concurrent antiarrhythmic medications (e.g., amiodarone or quinidine)

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Chronic Myeloproliferative Disorders
• Disease
• Leukemia
• Lymphoma
• Lymphoproliferative Disorder
• Lymphoproliferative Disorders
• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic Syndromes
• Myelodysplastic-Myeloproliferative Diseases
• Myelodysplastic/Myeloproliferative Neoplasms
• Myeloproliferative Disorders
• Neoplasms
• Neoplasms, Plasma Cell
• Nervous System Neoplasms
• Pain
• Precancerous Condition
• Precancerous Conditions
• Preleukemia
• Syndrome
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Drug:
• methadone hydrochloride
Given orally
• morphine sulfate
Given orally
• oxycodone hydrochloride
Given orally

Locations

Country	Name	City	State
United States	M. D. Anderson Cancer Center at University of Texas	Houston	Texas
United States	Palmetto Hematology Oncology, PC at Gibbs Regional Cancer Center	Spartanburg	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With at Least a 3-point Reduction in Pain Score on the M.D. Anderson Symptom Inventory (MDASI)	MDASI questionnaire completed on days 8, 15, and 22 after enrollment. The 'primary success' is defined as a 3-point reduction in pain score on the MDASI. Scores from baseline and from four weeks later compared using the MDASI average pain intensity on a scale of 0 (no pain) to 10 (worst pain).	28 days
Secondary	Number of Participants With 30% Reduction in Total Summary Score for the Individual Composite Drug Toxicity Score (CDTS) Items		28 days

External Links

•   University of Texas MD Anderson Cancer Center Official Website